Safety and effectiveness of tolvaptan for fluid management after pediatric cardiovascular surgery

Katayama, Yuzo; Ozawa, Tsukasa; Shiono, Noritsugu; Masuhara, Hiroshi; Fujii, Takeshiro; Watanabe, Yoshinori

doi:10.1007/s11748-017-0798-5

Cited by 13 publications

(15 citation statements)

References 20 publications

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“…Overall, nine studies in 430 children met our inclusion criteria, all of which were single centre. [18][19][20][21][22][23][24][25][26] Study characteristics are summarised in Table 1. Three studies were prospective trials, one was a post hoc analysis of a prospective trial, and five were retrospective cohort studies.…”

Section: Resultsmentioning

confidence: 99%

A systematic review of the evidence supporting post-operative diuretic use following cardiopulmonary bypass in children with Congenital Heart Disease

et al. 2021

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Background: Paediatric cardiac surgery on cardiopulmonary bypass induces substantial physiologic changes that contribute to post-operative morbidity and mortality. Fluid overload and oedema are prevalent complications, routinely treated with diuretics. The optimal diuretic choice, timing of initiation, dose, and interval remain largely unknown. Methods: To guide clinical practice and future studies, we used PubMed and EMBASE to systematically review the existing literature of clinical trials involving diuretics following cardiac surgery from 2000 to 2020 in children aged 0–18 years. Studies were assessed by two reviewers to ensure that they met eligibility criteria. Results: We identified nine studies of 430 children across four medication classes. Five studies were retrospective, and four were prospective, two of which included randomisation. All were single centre. There were five primary endpoints – urine output, acute kidney injury, fluid balance, change in serum bicarbonate level, and required dose of diuretic. Included studies showed early post-operative diuretic resistance, suggesting higher initial doses. Two studies of ethacrynic acid showed increased urine output and lower diuretic requirement compared to furosemide. Children receiving peritoneal dialysis were less likely to develop fluid overload than those receiving furosemide. Chlorothiazide, acetazolamide, and tolvaptan demonstrated potential benefit as adjuncts to traditional diuretic regimens. Conclusions: Early diuretic resistance is seen in children following cardiopulmonary bypass. Ethacrynic acid appears superior to furosemide. Adjunct diuretic therapies may provide additional benefit. Study populations were heterogeneous and endpoints varied. Standardised, validated endpoints and pragmatic trial designs may allow investigators to determine the optimal diuretic, timing of initiation, dose, and interval to improve post-operative outcomes.

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Section: Resultsmentioning

confidence: 99%

A systematic review of the evidence supporting post-operative diuretic use following cardiopulmonary bypass in children with Congenital Heart Disease

et al. 2021

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“…Five were excluded as they were not RCTs ( 1 , 7 , 9 , 13 , 14 ). One study was conducted on pediatric patients ( 15 ), and another on patients with chronic kidney disease ( 8 ). Finally, four studies were included in this systematic review and meta-analysis ( 2 , 16-18 ).…”

Section: Resultsmentioning

confidence: 99%

Efficacy of tolvaptan for fluid management after cardiovascular surgery: A systematic review and meta‑analysis of randomized control trials

Chen

Jiang

et al. 2020

Exp Ther Med

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The purpose of this study was to systematically search the literature and analyze evidence from randomized controlled trials (RCTs) comparing tolvaptan with conventional diuretics for postoperative fluid management in cardiac surgery patients. An electronic search of PubMed, Scopus, BioMed Central, CENTRAL (Cochrane Central Register of Controlled Trials) and Google scholar databases was carried out up to 1st December 2019. Four RCTs were included. Tolvaptan was co-administered with conventional diuretics in all the studies. The mean postoperative urine output was significantly greater in patients receiving tolvaptan as compared to controls (MD=0.39; 95% CI: 0.17 to 0.61; P=0.006, I 2 =48%). Body weight of patients on tolvaptan returned to pre-operative levels significantly earlier (MD=-1.57; 95% CI:-2.48 to-0.66; P=0.007, I 2 =50%). There was statistical significant difference in the highest postoperative serum sodium levels (MD=2.34; 95% CI:-1.65 to 3.03; p<0.00001, I 2 =0%), lowest serum sodium levels (MD=2.05; 95% CI: 1.41 to 2.68; p<0.00001, I 2 =0%) and mean serum sodium levels (MD=1.69; 95% CI: 0.98 to 2.40; p<0.00001, I 2 =0%) between the tolvaptan and control groups. Lowest serum potassium was significantly higher with tolvaptan as compared to the control group (MD=0.10; 95% CI: 0.01 to 0.18; P=0.03, I 2 =19%). There was no significant difference in the length of ICU stay or incidence of arrhythmias between the two groups. The quality of the included studies was not high. Within the limitations of our study, our results indicate that co-administration of tolvaptan with low dose of conventional diuretics significantly increases urine output while maintaining electrolyte balance in postoperative cardiac surgery patients. Faster return of body weight to pre-operative levels is evident with tolvaptan. Further high-quality RCTs are required to confirm this evidence.

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“…8 A pesar de que las dosis no están bien establecidas en pediatría, se ha utilizado en un rango de 0,1-0,75 mg/kg/día, repartidos en 1-2 veces. [8][9][10][11] El tolvaptán ha sido un fármaco seguro en nuestro caso, pues permitió reducir la dosis de otros diuréticos, mejorar la clase funcional y dar de alta a una paciente que dependía previamente de diuréticos intravenosos. Además de controlar los síntomas congestivos, la paciente presentó mejoría del FG de hasta el 56% con respecto al basal.…”

Section: Comentariosunclassified

Tolvaptán en un caso de síndrome cardiorrenal pediátrico. ¿Cuál es su papel?

Hernández

Martínez

Marín

et al. 2018

Arch Argent Pediatr

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The cardiorenal syndrome has been defined as a situation in which therapy to relieve congestive symptoms of heart failure is limited by a decreased renal function. The resistance to conventional diuretic treatment makes difficult managing these patients. Tolvaptan, a selective vasopressin-2 receptor antagonist, has been used successfully in adults with this pathology but the experience with children is very limited. A five-year-old girl with renal failure waiting for a heart transplant is presented. Tolvaptan (0.1 mg/kg/day) was started at very low dosage, resulting in an excellent response. We analyzed the creatinine, urea, urine volume and sodium evolution. Renal function also improved. She could be discharged after four days of treatment (156 days of hospitalization) with ambulatory favourable follow-up until heart transplant. Tolvaptan should be considered in pediatric cases of conventional diuretic-resistant congestive heart failure, especially when complicated by kidney disease.

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Safety and effectiveness of tolvaptan for fluid management after pediatric cardiovascular surgery

Abstract: Tolvaptan appears to be effective and safe for management of postoperative fluid retention after congenital heart surgery.

Cited by 13 publications

References 20 publications

A systematic review of the evidence supporting post-operative diuretic use following cardiopulmonary bypass in children with Congenital Heart Disease

A systematic review of the evidence supporting post-operative diuretic use following cardiopulmonary bypass in children with Congenital Heart Disease

Efficacy of tolvaptan for fluid management after cardiovascular surgery: A systematic review and meta‑analysis of randomized control trials

Tolvaptán en un caso de síndrome cardiorrenal pediátrico. ¿Cuál es su papel?

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